We have a new and exciting pharmaceutical career opportunity for a Pharmacovigilance Specialist to work within a rapidly expanding pharma company that specialises in the research and development of treatments for areas that have unmet medical need. This job will be based at their UK site in Cambridge.
- Responsible for providing medical expertise for review and analysis of the safety of the Company's investigational and post-marketing assigned products, to ensure consumer, prescriber and regulatory authority confidence.
- Provide core medical pharmacovigilance input where required into the product teams and drug safety expertise and support for clinical trials.
- Contribute to the compilation and writing of periodic safety update reports (PSURs) and development safety update reports (DSURs).
- Responsible for signal detection and evaluation, benefit-risk assessment, risk management plans (incorporating risk minimisation), due diligence, relevant labelling support and responding to Regulatory Authority safety queries, for both investigational and post-authorisation products.
- Act as ambassador for PV governance within and outside the company.
- Provide medical expertise and safety support to the team, including medical review of individual case safety reports.
- Safety surveillance (signal detection; signal evaluation; benefit risk assessment; risk mitigation) for all assigned products.
- Provide professional expertise and advice to internal staff as well as competent authorities, physicians, pharmacists and patients by close interaction and communication with regard to drug safety related issues.
- Provide safety input and labelling support (SmPC / PIL) for assigned products.
- Responsible for the content of aggregate reports (PSURs, DSURs etc.) for assigned products.
- Act as medically qualified safety expert - safety physician for assigned active moieties in clinical development, managing the drug safety and pharmacovigilance aspects of the clinical programme.
- Responsible for creation and maintenance of Risk Management Plans (RMPs) for assigned product(s).
- Responsible for providing safety expertise for questions/requests from competent authorities.
Skills and Requirements:
- Qualified physician (medical degree) with GMC registration
- Proven experience in clinical practice preferred following post-graduate training with significant knowledge of general medicine; experience within the pain, respiratory therapeutic areas preferred but other specialties may be considered.
- Broad experience in the pharmaceutical or biotechnology industry including specific experience in pharmacovigilance/drug safety & risk management for both investigational and post-authorisation products.
- Post-graduate training and/or diploma in pharmaceutical medicine
- Advance knowledge of applicable European laws and regulations relevant to pharmacovigilance; knowledge of global pharmacovigilance requirements, legislation and guidance.
- Broad medical / pharmacological knowledge in the medical areas / of the medicinal products relevant to the comapny beneficial.
- Previous experience in the conduct of due diligence.
- Advanced IT skills, experience in working with MS office
- Fluency in spoken and written English.
- Outstanding commitment, accurate and methodical approach to work, great sense of responsibility and reliability.
- Critical thinking skills and ability to analyse and evaluate aggregate safety data.
- Strategic risk management planning skills.
- Ability to work and prioritise under pressure, self-organisation skills, confident and competent to take lead role.
- Ability to work both autonomously and as part of a team.
- Ability to work collaboratively in a multi-functional cross-regional environment s to address and resolve issues relating to products and safety processes.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jon Stewart on +44 203 7520 318 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.